The FDA has broadened the indication for Gilead Sciences’ Trodelvy, approving it as a first‑line treatment for triple‑negative breast cancer and raising the stakes against a rival ADC from AstraZeneca and Daiichi Sankyo that was recently cleared for earlier use.
Originally approved in 2020 as a third‑line option, Gilead’s Trodelvy now moves to the front line of therapy for triple‑negative breast cancer. This shift is critical because the disease’s rapid progression often leaves patients too ill to benefit from later‑line treatments.
Triple‑negative breast cancer lacks estrogen, progesterone, and HER2 receptors, rendering receptor‑targeted therapies ineffective. Until last month, standard first‑line care consisted of chemotherapy combined with Merck’s Keytruda, an immune‑checkpoint inhibitor that blocks PD‑1 on T cells.
Because immunotherapy is not suitable for all patients, the May accelerated approval of AstraZeneca and Daiichi Sankyo’s Datroway is noteworthy. The clearance allows Datroway to be used upfront in patients who cannot receive Keytruda, offering a non‑immunotherapy first‑line option.
As with Datroway’s label, the updated indication for Trodelvy includes use in patients who cannot undergo immunotherapy. Additionally, the FDA has cleared Trodelvy in combination with Keytruda following Gilead’s supplemental trials evaluating the ADC with the checkpoint inhibitor. The new approval encompasses both intravenous Keytruda and its sub‑cutaneous formulation, Keytruda Qlex.
“This approval is heartening news for patients and the clinical community, and I believe offers a practice‑changing first‑line treatment option for all patients across PD‑L1 status,” said Dr. Sara Tolaney, chief of breast oncology at Dana‑Farber Cancer Institute and a principal investigator of the Trodelvy studies.
Trodelvy is an antibody‑drug conjugate that zeroes in on TROP2, a protein over‑expressed on many cancer cells, including triple‑negative breast cancer. Its 2020 approval made it the first TROP2‑directed ADC. Since then, the label has expanded to include metastatic urothelial cancer and metastatic hormone‑receptor–positive, HER2‑negative breast cancer. The agent has become a revenue driver, generating roughly $1.4 billion worldwide in 2025—a 6 % year‑over‑year rise.
Datroway, also a TROP2‑targeting ADC, was co‑developed by Daiichi Sankyo in partnership with AstraZeneca. Although Trodelvy entered the market earlier, Datroway has quickly gained approvals—three in the past 18 months—covering HR‑positive, HER2‑negative breast cancer, EGFR‑mutated lung cancer, and, most recently, first‑line triple‑negative breast cancer. The drug is still awaiting full market entry but may soon be used with Keytruda for triple‑negative disease, pending results of an ongoing Phase 3 combination trial.
Photo by Gilead Sciences
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